Medical Device Safety Act

[AI summary unavailable — showing source text] Medical Device Safety Act - Title I: Authority to Establish Standards - Authorizes the Secretary of Health, Education, and Welfare to establish standards, under the Federal Food, Drug, and Cosmetic Act, for medical devices when such action will protect public health and safety. Authorizes the Secretary to establish mandatory standards relating to the composition, properties, or performance of a medical device or class of medical devices. Provides that the Secretary may utilize conferences, workshops, and other means by which nongovernmental experts could participate in the development of standards. Allows any person adversely affected by such standards to refer the matter to an independent advisory committee for its recommendations. Title II: Premarket Clearance of Certain Medical Devices - Sets forth conditions for when a premarketing clearance is required. States that a device is to be deemed unsafe, unreliable, or ineffective when: (1) the device is not generally recognized by experts, qualified by scientific training or experience, to be safe, reliable, or effective for use under the conditions prescribed, suggested or recommended; and (2) the device is intended for or is used …